Spectral Instruments Inc: Medical Device Recall in 2025 - (Recall #: Z-1942-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Ami HTX.

Product Classification:

Class II

Date Initiated: May 13, 2025

Date Posted: June 25, 2025

Recall Number: Z-1942-2025

Event ID: 97035

Reason for Recall:

The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.

Status: Ongoing

Product Quantity: 34

Code Information:

Accession number 2510780-000

Distribution Pattern:

Voluntary or Mandated:

FDA Mandated